HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Lots, UDI (01)07630016832185 Not distributed within the US
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Advanced Bionics, LLC
- Reason for Recall:
- Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Product Codes/Lot Numbers:
All Lots, UDI (01)07630016832185 Not distributed within the US
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1259-2020
Related Recalls
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.